UDI EUDAMED Attributes

  • Multi-component devices are medical devices that are intended to be used in combination 
  • Medical devices that are not multi-component devices can either be a special device type devices or just a standard  device
  • Depending on the applicable legislation under which the medical device is authorized (MDR or IVDR) different types are possibble

 

Type of Multi-Component Device 

  • Product under MDR can be the following Type of Multi-Component Device: 
    • System: A combination of products, either packaged together or not, which are intended to be inter-connected or combined to achieve a specific medical purpose (e.g. syringe pumps and disposable syringes sold individually) 
    • Procedure Pack: A combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose (e.g. blood pressure monitor marketed in a pack together with a suitable disinfectant)
  • Product under IVDR can be the following Type of Multi-Component Device: 
    • Kit: A set of components that are packaged together and intended to be used to perform a specific in vitro diagnostic examination, or a part thereof (z.B. Covid test kit)

Special Device Type 

  • Product under MDR can be the following Special Device Type: 
    • Orthopaedic,
    • Rigid Gas Permeable (RGP) & Made-to-Order Soft Contact Lenses
    • Software
    • Standard Soft Contact Lense
  • Product under IVDR can be the following Special Device Type: 
    • Software

 

(Standard) Device 

  • If none of the above types of Type of Multi-Component Device and Special Device Type apply, it is a standard medical device
  • Procuts under MDR:
    • e.g. Chirurgische Zangen
  • Procuts under IVDR:
    • e.g. Covid Test Kit